Electrical Stimulation for Critically Ill Covid-19 Patients

NCT04685213 | Completed Phase 1 Results FDA Device

• 1 other identifier: H-47781-A
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Unfortunately, hospital-acquired weakness is highly prevalent among COVID-19 hospitalized patients, who often require prolonged bed-rest or paralytics for an extended period of time in order to maintain oxygenation. Prolonged bed rest has been associated with pronounced loss of muscle mass that can exceed 10% over the 1st week, which leads to functional impairment and complications post-hospital discharge. Physical therapy and in-hospital mobility program may reduce the incident of hospital-acquired weakness, but they are often impractical for COVID-19 patients. In particular, conventional mobility programs are challenging for those who are being treated in an intensive Care Unit. The purpose of this study is to test feasibility and proof-of-concept effectiveness of daily use of lower extremity electrical stimulation (EE) therapy, as a practical solution to address lower extremity muscle deconditioning, to address chronic consequences of COVID-19 including hospital-acquired weakness.

Conditions

Covid19; Muscle Atrophy; Muscle Weakness

Keywords

electrical stimulation; skin perfusion; Muscle dysfunction

Outcome Measures

Primary Outcomes (2)

• Change in Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation

  Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).

  an average of 2 weeks (Phase I)

• Change in Ankle Strength

  Ankle strength will be measured in response to the average of three 5-second dorsiflexion maximum voluntary isometric contractions per 30 seconds of relaxation in-between using a dynamometer (RoMech Digital Hanging Scale).

  an average of 2 weeks (Phase I)

Secondary Outcomes (1)

• Change in Plantar Tissue Oxygen Saturation/Consumption

  an average of 2 weeks (Phase I)

Other Outcomes (2)

• Likelihood of Falling

  an average of 2 weeks (Phase I)

• Change in Gastrocnemius Muscle Strength

  An average of 2 weeks (Phase I)

Study Arms (2)

Active E-Stim

ACTIVE COMPARATOR

Subjects will receive an active electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).

Device: Electrical Stimulation

sham E-Stim

SHAM COMPARATOR

Subjects will receive a sham electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).

Device: Electrical Stimulation - Sham

Interventions

Electrical Stimulation DEVICE

Subjects will receive an active electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).

Active E-Stim

Electrical Stimulation - Sham DEVICE

Subjects will receive a sham electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).

sham E-Stim

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COVID-19 test positive critically ill patients in need of assisted ventilation requiring care in the intensive care unit
• COVID-19 test positive critically ill patients in need of assisted ventilation requiring prolonged care in the hospital

You may not qualify if:

• Paralyzed patients (i.e., rocuronium, cisatracurium) at the moment of enrollment
• Patients under vasopressor therapy (i.e., norepinephrine, epinephrine, vasopressin) at the moment of enrollment
• Patients expected to be discharged in the next 24 hours
• Patient has a demand-type cardiac pacemaker, implanted defibrillator or other implanted electronic device.
• Active wound infection
• Below the knee amputations
• Based on the clinicians decision whether the patient is eligible for the study

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Avazzia, Inc: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Zulbaran-Rojas A, Mishra R, Rodriguez N, Bara RO, Lee M, Bagheri AB, Herlihy JP, Siddique M, Najafi B. Safety and efficacy of electrical stimulation for lower-extremity muscle weakness in intensive care unit 2019 Novel Coronavirus patients: A phase I double-blinded randomized controlled trial. Front Med (Lausanne). 2022 Dec 6;9:1017371. doi: 10.3389/fmed.2022.1017371. eCollection 2022.

  PMID: 36561714 DERIVED

MeSH Terms

Conditions

COVID-19; Muscular Atrophy; Muscle Weakness

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Results Point of Contact

• Title: Prof. Bijan Najafi
• Organization: Baylor College of Medicine

bijan.najafi@bcm.edu

7137987536

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Devices may be active or sham.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: Participants will be randomized to intervention (IG) or control group (CG) with ratio of 1:1. The entire cohort will receive daily electrical stimulation (EE) in lower extremity (e.g. Gastronemius muscle) for up to 1 hour. The EE device will be functional for IG and non-functional for CG. Phase I will include patients (n=19) admitted to the hospital due to severe COVID-19 infection. The time frame for therapy will be 2 weeks or until hospital discharge, whichever comes first.

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 28, 2020
• Study Start: December 22, 2020
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: February 16, 2023
• Results First Posted: January 18, 2022

Record last verified: 2023-02

Locations

US (1)